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Enrolling By Invitation
NCT07845305
INtubation With Sedation Only to Preserve Independent Respiratory Effort Trial
Conditions: Acute Respiratory Failure
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 228
Sponsor: Vanderbilt University Medical Center
Location: Vanderbilt University Medical Center Nashville Tennessee
Summary
The INtubation with Sedation Only to Preserve Independent Respiratory Effort (INSPIRE) trial is a pragmatic, non-blinded, parallel-group, randomized clinical trial comparing the effect of intubation with sedation only (intervention group) versus intubation with sedation plus neuromuscular blockade (control group) among adults undergoing emergency tracheal intubation in the ED and ICU with regard to the outcomes of: (1) hypoxemia during intubation, (2) successful intubation on the first attempt, and (3) awake immobility and PTSD symptoms. Patients who are determined by treating clinicians to require emergency tracheal intubation and who meet eligibility criteria will be enrolled and randomly assigned to either intubation with sedation only or intubation with sedation plus neuromuscular blockade.
Eligibility Criteria
Inclusion Criteria:
1. Patient is undergoing emergency tracheal intubation with the use of sedation in a participating unit
2. Clinician willing to use a video-laryngoscope for the intubation
Exclusion Criteria:
1. Patient is known to be less than 18 years old
2. Patient is known to be pregnant
3. Patient is known to be a prisoner
4. Clinician has determined that use of a direct laryngoscope, bronchoscope, or an intubating laryngeal mask airway is required for the optimal care of the patient.
5. Patient or Legally Authorized Representative declines participation during pre-enrollment conversation or by wearing opt-out bracelet for the INSPIRE trial
6. Clinician has determined that a neuromuscular blocking agent is required or contraindicated for the optimal care of the patient
7. Immediate need for tracheal intubation precludes safe performance of study procedures
Source: ClinicalTrials.gov (NCT07845305). StuddyBuddy aggregates publicly available trial information.